BS EN 16615:2015

BS EN 16615:2015 (Phase 2, Step 2)
General Purpose Disinfection
Mandatory test Organisms
Enterococcus hirae
Pseudomonas aeruginosa
Staphylococcus aureus
Candida albicans
Test Temperature
In a range from 4 °C to 30 °C
Contact time
A minimum of 1 minute and a maximum of either 5 or 60 minutes
Clean or Dirty depending on manufacturers usage instructions
Log reduction required to receive a pass
>5 Log for Bacteria
>4 Log for Yeast

The EN 16615 is the phase 2 step 2 test for disinfectant products in the medical market.  Although the test is for the medical market wipe products for any market are also expected to have the EN 16615 carried out due to the nature of the test.  The EN 16615 has 4 obligatory organism which will give you both the bactericidal and yeasticidal claim.  A phase 2 step 2 test is mandatory for ECHA and BPR so most people opt for EN 16615 when selling a surface disinfectant in the medical market.  Previously some people opted of the EN 13697 instead, but this is becoming less common.

The EN 16615 is a surface test rather than a suspension test meaning the product doesn’t have to be diluted if it a ready to use product.  For the EN 16615 we have floor tiles made to a spec from the standard.  On these tiles there are four sections which are know as section 1-4.  In section 1 we add a known number of organisms and interfering substance.  These are then dried.  Once the organism solution is dry, we take the wipe product ad wrap it around a weighted block. The wipe is then pushed up the tile, turned and pulled back down.  The wipe starts before section 1 and then is pushed over section 2-4. Once the wipe has gone over the tile, we leave it for the contact time.  After the contact time is up, we test each section individually.  The solution from each section is then plated out on the appropriate agar in a dilution series and incubated.  Once the organisms have had time to grow, they are counted and a log reduction is worked out.  The reduction is based off a water wipe that also goes through the test.  The test 1 section is what they initial log reduction is work out off but you also can’t have too many colonies in section 2-4 otherwise the product will fail regardless of the outcome of the section one.  This is to show the wipe is actually disinfecting not just dragging the organisms around.

Regardless of if the product is a wipe or not this test can still be performed.  If the product is a disinfection solution, we can add it to Tork wipes we have here.  This Tork wipes are specified in the standard and are used for the reference as well.  On the other hand, if you have a specific wipe cloth we can also test on this instead.

Many different organisms can be added to the EN 16615 just like with most standards.  As there are only a limited amount of phase 2 step 2 tests it is common to have things like mycobacteria or spores added on as there isn’t specific methods for these like there are in the suspension tests.  Another thing that can be done on the EN 16615 is viruses.  There isn’t a phase 2 step 2 test for viruses that included mechanical action so many people modify this method more disinfectant wipes.

For BRP submission 2 concentrations are required for testing in the EN 16615 which is the only test that doesn’t require 3 concentrations.  If you have a wipe product then we can do the second concentration by extracting the wipe fluid, diluting it and adding the amount specified by you onto a dry wipe.

The table shows what the standard states as the test parameters but often the NHS will insist on different conditions.  This could be 30 second contact time or dirty conditions even when the standards state oterhwise.  If you are testing for a specific tender, you should check the requirements of this before testing.

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